Onychomycosis
Conditions
Keywords
Toenail, Fungal Infections, DSO
Brief summary
To determine the safety, tolerability, systemic exposure and pharmacokinetics of luliconazole after repeat daily topical application of Luliconazole Solution, 10% in a maximal use setting in adults with distal subungual onychomycosis of the toenails.
Interventions
28 days of daily application
Sponsors
Topica Pharmaceuticals
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* 18-65 years * Distal Subungual Onychomycosis(DSO)on both great toenails with \>=50%involvement of at least 1 great toenail * At least 4 additional toenails with DSO * Positive KOH and culture * Normal renal and hepatic function
Exclusion criteria
* Subjects with hypersensitivity to imidazole compounds or any other ingredient * Subjects unwilling to refrain from use of nail cosmetics until end of study * Subjects with symptomatic tinea pedis * Subjects with any history of cardiac disease of cardiac rhythm abnormalities * Female subjects who are pregnant, nursing, or planning a pregnancy * Subjects who have not undergone the specified washout period(s) for the following or requiring the concurrent use of: topical antifungal within 4 weeks; topical anti-inflammatory, corticosteroids, topical immunomodulators within 2 weeks; systemic corticosteroids within 2 weeks; systemic immunomodulators within 4 weeks. * Subjects receiving systemic antifungals for treatment of onychomycosis or any systemic antifungal with known activity against dermatophytes within the previous 12 weeks or 5 half-lives of the drug, whichever is longer * Subjects receiving any other treatment/therapy for the onychomycosis not previously mentioned (e.g., laser treatment) within 4 weeks * Subjects with a history of significant internal disease or with a life threatening condition within the last 6 months * Subjects with anatomic abnormalities of the toe(s) and or toenails * Subject who have donated or lost a large volume of blood (\ 500 mL or more, during the previous 6 weeks * Subjects with a recent history of or currently known to abuse drugs or alcohol * Subjects currently participating in another investigational medication or device study or have participated in a clinical trial within 30 days or five half-lives of the test medication
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PK parameters (AUC, Cmax, Tmax, t1/2) will be measured at days 1 (Baseline), 9, 15 and 29. Safety assessments include monitoring of adverse events, local site tolerability, ECG monitoring, and changes in laboratory values and vital signs. | March 2011 |
Secondary
| Measure | Time frame |
|---|---|
| Evaluation of linear toenail growth. | March 2011 |
Countries
United States
Outcome results
None listed